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A Pilot Study of Intraosseous Infusion of Unrelated Cord Blood Grafts

36 Months
60 Years
Not Enrolling
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome

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Trial Information

A Pilot Study of Intraosseous Infusion of Unrelated Cord Blood Grafts

Hematopoietic (blood forming) stem cells (HSCs) reside primarily in the bone marrow.
Traditionally, HSCs have been obtained directly from the bone marrow. Transplants using
cells obtained this way are referred to as bone marrow transplants. HSCs also circulate in
the blood. Transplants using cells obtained from the blood of children and adults are
referred to as peripheral blood stem cell transplants. The blood of fetuses is especially
rich in HSCs and these cells can be easily collected at birth from the placenta.
Transplants using these cells are called cord blood transplants. Although HSCs can be
collected from various sites, all HSC transplants, regardless of the source, are given to
recipients by intravenous infusion. The transplanted HSCs then migrate to the bone marrow.

Over the past ten years unrelated cord blood transplantation has become an accepted
alternative to bone marrow transplantation. African-Americans and other minorities, who are
underrepresented in the National Marrow Donor Program, have benefited particularly from
this. In infants and young children cord blood transplantation appears to be as effective as
bone marrow transplantation. In older children, adolescents and adults, however, cord blood
transplantation has not been as effective, primarily because most cord blood units provide
an insufficient number of cells to ensure prompt and reliable engraftment ("taking" of the
transplanted cells in the recipient's bone marrow).

Inclusion Criteria:

1. Age 36 months to 60 years old (YO)

2. No prior autologous or allogeneic transplant

3. Karnofsky performance score or Lansky Play-Performance of at least 80

Exclusion Criteria:

1. Age < 36 months or > 60 YO

2. creatinine clearance or nuclear medicine GFR of < 50 mL/min

3. cardiac ejection fraction < 50%

4. bilirubin > 2 × upper limit of normal or ALT > 4 × upper limit of normal or
unresolved veno-occlusive disease

5. Pulmonary carbon monoxide diffusing capacity (DLCO), adjusted for Hgb < 50%

6. Karnofsky performance score or Lansky Play-Performance Scale <80

7. Uncontrolled viral, bacterial, or fungal infection at the time of study enrollment

8. Seropositive for HIV

9. Availability of a willing and well HLA matched related (genotypically identical or
mismatched at a single allele or antigen defined by typing at HLA A, B, C and DRB1
loci) donor

10. Availability of a willing and well HLA matched unrelated (allele matched or
mismatched at a single allele defined by allele level typing for HLA A, B, C and DRB1
loci) adult blood or marrow donor

11. Availability of an umbilical cord blood unit, which provides at least a 4/6 HLA match
as defined above and ≥ 5.0 * 107 NC/Kg (cryopreserved)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compare the rapidity of myeloid engraftment of intraosseously and intravenously administered unrelated cord blood grafts.

Outcome Time Frame:

1 year after last patient enrolled

Safety Issue:


Principal Investigator

John Horan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University


United States: Institutional Review Board

Study ID:

Intraosseous Infusion



Start Date:

March 2007

Completion Date:

July 2011

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • AML
  • ALL
  • leukemia
  • CML
  • Myelodysplastic Syndrome
  • malignancies
  • Undifferentiated leukemia
  • High risk malignancies
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia



Emory UniversityAtlanta, Georgia  30322
Children's Healthcare of AtlantaAtlanta, Georgia  30342